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Trial registered on ANZCTR


Registration number
ACTRN12614000787684
Ethics application status
Approved
Date submitted
15/07/2014
Date registered
24/07/2014
Date last updated
2/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Online treatment to improve sleep after brain injury
Scientific title
Following brain injury can an online cognitive behavioural intervention in comparison to education improve sleep
Secondary ID [1] 282388 0
Nil
Universal Trial Number (UTN)
U1111-1142-2641
Trial acronym
SleepWell4Recovery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 288969 0
Condition category
Condition code
Injuries and Accidents 289307 289307 0 0
Other injuries and accidents
Neurological 292850 292850 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online sleep intervention is an adapted programme based on the Return2Sleep programme developed by Associate Professor Norah Vincent in Canada for people with insomnia. The programme contains interactive tasks and strategies to improve sleep. The programme has been adapted to facilitate its use for people with brain injury and the difficulties they experience. The programme contains 6 modules. Each module is completed once per week for 20 minutes for 6 weeks at the participant's home at a time convenient to them.
Intervention code [1] 289826 0
Rehabilitation
Comparator / control treatment
Online information resource providing information only on sleep and brain injury. Advice based on sleep hygiene principles is included. The education control programme contains 6 modules. Each module is completed once per week for 20 minutes for 6 weeks at the participant's home at a time convenient to them.
Control group
Active

Outcomes
Primary outcome [1] 292662 0
Global self-reported sleep quality using the Pittsburgh Sleep Quality Index
Timepoint [1] 292662 0
6 weeks post-randomisation (post-intervention)
Primary outcome [2] 292663 0
Average objective sleep quality as assessed by actigraphy for a 2 week period.
Timepoint [2] 292663 0
6 weeks post randomisation (post-intervention)
Secondary outcome [1] 309440 0
Cognitive functioning as assessed by the CNS Vital Signs (computerised neuropsychological assessment) Neurocognition index score.
Timepoint [1] 309440 0
6 weeks post randomisation (post-intervention)
Secondary outcome [2] 309441 0
Quality of life as assessed by the Quality of Life after Brain Injury Scale (QoOLIBRI)
Timepoint [2] 309441 0
6 weeks post-randomisation (post-intervention)
Secondary outcome [3] 309442 0
Post-concussion symptoms as assessed by the Rivermead Post Concussion Symptom Scale
Timepoint [3] 309442 0
6 weeks post-randomisation (post-intervention)
Secondary outcome [4] 309443 0
Depression as assessed by the Center for Epidemiologic Stuydies- Depression Scale (CES-D)
Timepoint [4] 309443 0
6 weeks post-randomisation (post-intervention)

Eligibility
Key inclusion criteria
Between 3 months and 3 years post-TBI
Have self-reported difficulty initiating and/or maintaining sleep for more than 3 months with a score of 8 or more on the Pittsburgh Sleep Quality Index indicating presence of clinically significant sleep difficulties
Access to high speed internet.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent;
Unable to read English (at level required to read a local newspaper);
Present with symptoms indicative of an untreated sleep disorder with an underlying physical cause
Harmful or hazardous drinking as assessed by a score of 8 or more on the Alcohol Use Disorders Identification Test
Undertaking shift work
Have a medically unstable condition that could impact on the results (e.g. experiencing severe psychosis, as assessed by Mini International Neuropsychiatric Interview Version 6 (MINI) Receiving current support from sleep services.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be screened via the telephone to ensure they meet the inclusion criteria. If eligible, the first assessment will be conducted in-person at the participant’s home (or preferred location) to obtain written consent and medical and sleep history. Participants identified as needing investigation for a possible sleep disorder will be referred to their general practitioner. Participants will be recruited through TBI service providers, self referral and community health care services. Participants will be allocated to groups by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to receive one of two online treatment programmes using stratified block randomisation to uphold balance of recruitment site and injury severity [mild, moderate, severe] between the groups. Minim randomisation software will be used to conduct the randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of covariance will be used to obtain mean differences between the treatment arms, adjusting for baseline measurement, at each time-point. Covariates displaying chance imbalance will be assessed for confounding and potentially contribute to results adjustment. Missing covariate data in fewer than 20% of cases in either arm will be multiply imputed; in other cases the covariate will be eliminated from consideration. No outcome data will be imputed. Normality of the residuals will be evaluated and appropriate modifications of the analyses applied if necessary. The need to allow for clustering within centre will be assessed using appropriately applied F-tests. Primary analyses will be carried on an intention-to-treat analysis set, although per protocol analyses will also be conducted. The sample size was determined based on enabling sufficient diversity in participant characteristics including ethnicity and TBI severity. As this is a feasibility study no formal power calculations have been conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6219 0
New Zealand
State/province [1] 6219 0
Auckland/Hamilton

Funding & Sponsors
Funding source category [1] 289607 0
Government body
Name [1] 289607 0
Health Research Council of New Zealand
Address [1] 289607 0
Level 3, 110 Stanley Street, Auckland, 0629
Country [1] 289607 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
AUT City Campus
Wellesley Street
Auckland
New Zealand
1142
Country
New Zealand
Secondary sponsor category [1] 288290 0
None
Name [1] 288290 0
Address [1] 288290 0
Country [1] 288290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291343 0
Health and Disability Ethics Committee
Ethics committee address [1] 291343 0
Ministry of Health
Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Ethics committee country [1] 291343 0
New Zealand
Date submitted for ethics approval [1] 291343 0
Approval date [1] 291343 0
19/05/2014
Ethics approval number [1] 291343 0
14/NTB/63

Summary
Brief summary
Many people who have had a traumatic brain injury experience on-going sleep difficulties that can have a significant impact on their ability to function in everyday life. Online treatments to improve sleep have been found to be effective for people with insomnia, however people with brain injury have been excluded from previous clinical trials. This feasibility study will examine if two online treatments can help to improve sleep for people following a brain injury. 36 people who have experienced a brain injury in the last 2 months to 3 years will be randomised to receive one of two online programmes that last for 6 weeks. Participants sleep quality and other outcomes influenced by sleep (such as cognitive functioning, mood) will be assessed before and after the treatment so that we can compare the results between the two groups.
Trial website
www.nisan.aut.ac.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39522 0
Dr Alice Theadom
Address 39522 0
AR417, 90 Akoranga Drive, AUT North Shore Campus, Northcote, Auckland, 0627
Country 39522 0
New Zealand
Phone 39522 0
+64 9 921 9999 x 7805
Fax 39522 0
Email 39522 0
alice.theadom@aut.ac.nz
Contact person for public queries
Name 39523 0
Dr Alice Theadom
Address 39523 0
AR417 90 Akoranga Drive, AUT North Shore Campus, Northcote, Auckland, 0627
Country 39523 0
New Zealand
Phone 39523 0
+64 9 921 9999 x 7805
Fax 39523 0
Email 39523 0
alice.theadom@aut.ac.nz
Contact person for scientific queries
Name 39524 0
Dr Alice Theadom
Address 39524 0
AA254C, 90 Akoranga Drive, AUT North Shore Campus, Northcote, Auckland, 0627
Country 39524 0
New Zealand
Phone 39524 0
+64 9 921 9999 x 7805
Fax 39524 0
Email 39524 0
alice.theadom@aut.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary